The BD Liverty™ TIPS Stent Graft Study (NCT05711316) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The BD Liverty™ TIPS Stent Graft Study
United States, France, Germany177 participantsStarted 2023-08-08
Plain-language summary
The objective of the study is to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension from cirrhosis. This includes recurrent or refractory ascites, hepatic hydrothorax, and/or variceal bleeding (esophageal and/or gastric).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject must voluntarily sign and date the approved Informed Consent Form (ICF) prior to the conduct of any study-specific procedures including any procedure required to determine subject eligibility (apart from those conducted as part of the subject's routine clinical management).
. The subject must be ≥18 years of age with a life expectancy of ≥12 months to allow for adequate completion of study procedures and collection of data.
. The subject must be willing and able to comply with protocol requirements, including all study visits and procedures.
. The subject must have a diagnosis of portal hypertension from cirrhosis with at least one of the following indications for de novo TIPS creation including:
. Recurrent, or Refractory Ascites (defined as ascites that cannot be mobilized or recurs after large volume paracentesis despite dietary sodium restriction and diuretic therapy)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying the BD Liverty TIPS stent graft for portal hypertension — is this specific device meaningfully different from the TIPS stent already used in standard care, and what might that mean for me?
2The trial is no longer enrolling new patients — does that mean results or safety data might be available soon that my doctor could review to help inform my treatment decision?
3One of the key things this study is tracking is 'shunt dysfunction' over six months — how common is that complication with existing TIPS procedures, and how would we know if it happened to me?
4The trial also measures 'major complications' in the first 30 days after the procedure — what kinds of complications are they watching for, and how does that risk compare to my other treatment options for portal hypertension?
5Since this trial isn't a traditional numbered phase, what does that tell us about how much safety and effectiveness data already exists for this device, and should I consider a standard TIPS procedure first instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom from Major Complications through 30 days post-Index Procedure
Timeframe: 30 days
2
Freedom from Shunt Dysfunction through 6 months post-Treatment Completion
. Esophageal Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Esophageal Variceal Bleeding, or Recurrent Esophageal Variceal Bleeding
. Gastric Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Gastric Variceal Bleeding, or Recurrent Gastric Variceal Bleeding
Exclusion criteria
. The subject is pregnant. Subjects of child-bearing potential must have a negative pregnancy test (urine or serum).
. The subject has undergone prior transcatheter procedures for the treatment of complications from portal hypertension (e.g., TIPS, surgical shunt creation, peritoneovenous shunt, retrograde transvenous obliteration (-RTO)). Note: Subjects with variceal bleeding that have undergone -RTO at least 8 weeks prior to the planned Index Procedure may be enrolled.
. The subject has undergone prior stent or stent graft placement in the hepatic vein, portal vein and/or inferior vena cava (IVC).
. The subject is hemodynamically unstable with uncontrolled bleeding.
. The subject has hepatic and/or portal vein thrombosis (PVT). Note: Subjects with partial non-flow-limiting, non-malignant PVT may be enrolled.
. The subject has undergone prior liver transplant or is a current transplant candidate that is likely to undergo liver transplant within 6 months of enrollment.
. The subject has extrahepatic or hepatic malignancy or a history of previous hepatic malignancy, unless treated curatively ≥5 years prior to enrollment.
. The subject has overt (West Haven Criteria Grade ≥2), controlled or uncontrolled hepatic encephalopathy.